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Phase behavior of TPGS–PEG400/1450 systems and their application to liquid formulation: A formulation platform approach

dc.contributor.authorLi, Jinjiangen_US
dc.contributor.authorYang, Beien_US
dc.contributor.authorLevons, Jaquanen_US
dc.contributor.authorPinnamaneni, Swathien_US
dc.contributor.authorRaghavan, Krishnaswamyen_US
dc.date.accessioned2011-11-10T15:39:01Z
dc.date.available2013-01-02T16:32:36Zen_US
dc.date.issued2011-11en_US
dc.identifier.citationLi, Jinjiang; Yang, Bei; Levons, Jaquan; Pinnamaneni, Swathi; Raghavan, Krishnaswamy (2011). "Phase behavior of TPGS–PEG400/1450 systems and their application to liquid formulation: A formulation platform approach." Journal of Pharmaceutical Sciences 100(11): 4907-4921. <http://hdl.handle.net/2027.42/87132>en_US
dc.identifier.issn0022-3549en_US
dc.identifier.issn1520-6017en_US
dc.identifier.urihttps://hdl.handle.net/2027.42/87132
dc.description.abstractVitamin E d ‐alpha‐tocopheryl polyethylene glycol succinate (TPGS) and polyethylene glycol are common excipients used in both preclinical and commercial formulations. In this paper, the phase diagrams of TPGS and polyethylene glycol 400 (PEG 400) in the presence of either water or ethanol were constructed. The effect of water and ethanol on the cloud point temperature of TPGS–PEG 400 mixtures was investigated. In general, the cloud point temperature was reduced by the presence of either water or ethanol in the formulation. However, water was more effective in lowering the cloud point temperature than ethanol. Similarly, the phase diagram of TPGS–PEG 1450 was constructed. The cloud point temperature was observed to decrease with increasing TPGS concentration. It was found that TPGS and PEG 1450 could form a single phase when TPGS concentration was above 75%, based on differential scanning calorimetry, and FT‐Raman analysis indicated that a vibration at 1330 cm –1 disappeared in the melted single phase. In addition, a systematic melting point depression was observed for the mixtures of TPGS–PEG 1450. In the presence of Ibuprofen, a model compound, the cloud point temperature was also reduced. Finally, the extended Flory–Huggins theory for polymer solution was used to analyze the entropic and enthalpic contributions of water and ethanol to the free energy of mixing. © 2011 Wiley‐Liss, Inc. and the American Pharmacists Association J Pharm Sci 100:4907–4921, 2011en_US
dc.publisherWiley Subscription Services, Inc., A Wiley Companyen_US
dc.subject.otherPolymersen_US
dc.subject.otherPhysical Stabilityen_US
dc.subject.otherThermal Analysisen_US
dc.subject.otherPrecipitationen_US
dc.subject.otherFormulationen_US
dc.subject.otherRaman Spectroscopyen_US
dc.subject.otherSemi‐Solidsen_US
dc.subject.otherSurfactantsen_US
dc.subject.otherX‐Rayen_US
dc.subject.otherPowder Diffractometryen_US
dc.titlePhase behavior of TPGS–PEG400/1450 systems and their application to liquid formulation: A formulation platform approachen_US
dc.typeArticleen_US
dc.rights.robotsIndexNoFollowen_US
dc.subject.hlbsecondlevelPharmacy and Pharmacologyen_US
dc.subject.hlbtoplevelHealth Sciencesen_US
dc.description.peerreviewedPeer Revieweden_US
dc.contributor.affiliationumSchool of Pharmacy, University of Michigan, Ann Arbor, Michigan 48109en_US
dc.contributor.affiliationotherDrug Product Science & Technology, Bristol–Myers Squibb Company, New Brunswick, New Jersey 08903en_US
dc.contributor.affiliationotherDrug Product Science & Technology, Bristol–Myers Squibb Company, New Brunswick, New Jersey 08903. Telephone: +732‐227‐6584; Fax: +732‐227‐3784en_US
dc.identifier.pmid21656767en_US
dc.description.bitstreamurlhttp://deepblue.lib.umich.edu/bitstream/2027.42/87132/1/22659_ftp.pdf
dc.identifier.doi10.1002/jps.22659en_US
dc.identifier.sourceJournal of Pharmaceutical Sciencesen_US
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dc.owningcollnameInterdisciplinary and Peer-Reviewed


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